AstraZeneca Pharmaceuticals LP
FDA inspection history in Gaithersburg, Maryland, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Gaithersburg, Maryland.
Cited most
Across all AstraZeneca Pharmaceuticals observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.194(a)(4)Laboratory records1
- 21 CFR 211.198(a)Complaint files1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete AstraZeneca Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Gaithersburg, Maryland
One Form 483 · 2024 · 4 observations
Latest: Form 483, May 31, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-31 | 483 Form 483 | Gaithersburg, Maryland | 4 | $99 |
Investigators on these documents
Ekaterina Allen (1)James R. Birkenstamm (1)Jazmine N. Brown (1)
FEI number 1000198729 · most recent document May 31, 2024
About AstraZeneca Pharmaceuticals LP
How many FDA Form 483s has AstraZeneca Pharmaceuticals LP received?
FDA Intel has 1 Form 483 on file for AstraZeneca Pharmaceuticals LP; the most recent is dated May 31, 2024.
When was AstraZeneca Pharmaceuticals LP last inspected by FDA?
The most recent FDA inspection document on file for AstraZeneca Pharmaceuticals LP is a Form 483 dated May 31, 2024, for the site in Gaithersburg, Maryland.
What did FDA cite at AstraZeneca Pharmaceuticals LP?
The regulations cited most in the observations on file for AstraZeneca Pharmaceuticals LP are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194(a)(4) (Laboratory records), 1 time; 21 CFR 211.198(a) (Complaint files), 1 time.